A Phase I, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics and Food Effect of BVL-GSK098 Administered as Single and Multiple Oral Doses to Healthy Volunteers

BioVersys AG2 个研究点分布在 1 个国家目标入组 80 人开始时间: 2020年12月2日最近更新: 2023年1月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: BioVersys AG
入组人数: 80
试验地点: 2
主要终点: Number of participants with clinically significant abnormal findings in vital signs

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase I single-center, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics and food effect of BVL-GSK098 administered as single and multiple oral doses to healthy volunteers

详细描述

This is an exploratory, first-in-human (FIH), double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098. Part B is a MAD study to determine the safety, tolerability and PK of BVL-GSK098 following multiple daily oral doses in healthy volunteers.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-blind

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Volunteers aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body mass index (BMI) with a minimum weight of 50 kg or men and 45 kg for women, at the time of signing the informed consent.
•Volunteers who are healthy as determined by the investigator based on medical evaluation including medical history, physical examination and cardiac monitoring.
•Volunteers who have a clinically acceptable temperature, blood pressure and pulse rate in supine and standing position (systolic blood pressure between 100-140 mm Hg/ diastolic blood pressure between 50-90 mm Hg / HR between 50-100 bpm). Blood pressure and pulse will be measured after a minimum of 3 minutes of resting.
•Volunteers whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
•Male volunteers must use appropriate contraception (e.g. condoms as part of a double barrier method) from the time of the first dose until 3 months after the post-study visit.
•A female volunteer is eligible to participate if she is of non-childbearing potential, defined as:
•Is equal to or older than 45 years of age and has not had menses for greater than 1 year,
•Amenorrheic for less than 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation,
•Whose status is post hysterectomy, oophorectomy or tubal ligation.
•Nonsmokers (i.e., one who has abstained from use of tobaccco and other nicotine-containing products for the last 6 months).
•Willingness to stay in the investigational site for up to 11 days.
•Volunteers are capable of giving signed informed consent which included compliance with the requirements and restrictions listed in the consent form and in this protocol.

排除标准

•Women of childbearing potential
•Pregnant or lactating women
•Men with female partners who are lactating or are pregnant
•Glomerular Filtration Rate (GFR) < 90 mL/min/1.73m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration formula.
•Alanine aminotransferase (ALT), Gamma glutamyl transferase (GGT), Aspartate aminotransferase (AST), alkaline phosphatase or serum bilirubin levels must not exceed the upper limit of normal (ULN)
•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
•A positive test for HIV antibody.
•A positive pre-study drug/alcohol screen.
•Volunteers who consume more than 21 units of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 30 mL of 40% of alcohol by volume distilled spirits).
•Volunteers who are study site employees, or immediate family members of a study site or sponsor employee.
•Volunteers with ECG abnormalities (history, or evidence of second-degree heart block of Mobitz type II, third degree heart block, or any abnormality considered relevant by the Investigator), QTcB or QTcF >450 ms or PR>220 ms).
•Volunteers with a history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
•History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
•History of seizures.
•Volunteers who have received any prescribed systemic or topical medication within 4 weeks of the first dose administration.
•Volunteers who have used any non-prescribed systemic or topical medication (including herbal remedies) or megadose vitamins (i.e. 20 to 600 times the recommended daily supplement dose) within 7 days of the first dose administration, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
•Volunteers who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration.
•Volunteers who have participated in other clinical trials during the previous 90 days (drug to drug period) in which an investigational drug or a commercially available drug was tested.
•Exposure to more than 4 new chemical entities in the last 12 months before the first dosing day in this study.
•Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period.
•Failure to satisfy the investigator of fitness to participate for any other reason

研究组 & 干预措施

Single Ascending Dose (SAD)

Experimental

There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo.

干预措施: BVL-GSK098 capsule, placebo (Drug)

Multiple Ascending Dose (MAD)

Experimental

There are multiple dose levels or cohorts. Each cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo.

干预措施: BVL-GSK098 capsule, placebo (Drug)

Food Effect

Experimental

This cohort has 6 subjects randomized to BVL-GSK098 and 2 subjects randomized to placebo. Each participant will receive a single oral dose of BVL-GSK098 or placebo administered after the participant eats a high-fat, high calorie breakfast.

干预措施: BVL-GSK098 capsule, placebo (Drug)